Change Control Manager
New Cairo City, Egypt Change Control Manager
About the job Change Control Manager
Job ObjectiveChange Control Manager will perform technical management and supervision of change controls, including changes to processes, systems and technology, work roles, and organization structures,
determining and evaluating the impact of these changes and their implementation on the product licenses approved by Health Competent Authorities.
Key responsibilityEstablish a defined change control process to approve or reject the change and involves appropriate stakeholders, including but not restricted to Manufacturing, Quality, and Regulatory Affairs personnel.
Coordinate the reception of change control request and determine the areas involved for further evaluation by each of them.
Compile global evaluation and determine if there is a Regulatory impact on the Final product licenses as well as in the licenses of Blood Establishments involved in the change.
Determine data (existing and/or to be newly generated) needed to support the change and accordingly develop study protocols describing the methods, prospective acceptance criteria as well as additional post-implementation process performance and/or product quality monitoring as necessary Control that all the steps to be taken for final implementation have been done before the implementation.
Ensure implementation by reviewing that the change as implemented remains aligned with the relevant study protocols, and relevant documentation and perform an assessment of data generated to demonstrate that the change objective and acceptance criteria were met.
Provide guidance to Quality specialists under his/her responsibility.
Academic Experience Required Bachelor s Degree in Health-related Sciences.
Post-Graduate Certification in Quality Management.
Professional Experience Required Knowledge of cGMP requirements preferred.
Minimum of 4 years of Management or technical leadership experience is required.
Minimum of 6 years of related experience in Change Controls field in Pharmaceutical company.
Computing SkillsMS Office knowledge.
Personal Skills Organized and able to manage time effectively.
Ability to work within a highly regulated, labor intensive environment.
Ability to understand, explain, follow, and enforce SOPs and protocols.
Ability to plan, communicate and execute activities for the improvement of overall operations.
Strong integrity and commitment to Quality and Compliance.
Ability to work in groups and with other departments.
Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
LanguagesWritten and fluent spoken English and Arabic, preferable.
